Why more troubles lie ahead.
Sophisticated software allows health authorities to troll huge databases looking for possible drug dangers. The data mining can detect rare side effects that didn’t show up in clinical trials. But it can also raise false alarms and force regulators to divert time and money from more pressing dangers.” These words come from today’s Wall Street Journal page one article “A Risk in Cholesterol Drugs Is Detected, but Is It Real?” Although the article is not directly related to the current controversy over Avandia it does point to a major problem facing physicians, the FDA and pharmaceutical companies; how do we go about determining an acceptable level of risk?
One would be hard pressed to find a drug that does not have any adverse side effects. This is particularly true for drugs used to treat chronic disease states such as diabetes. There is no cure for diabetes therefore all a patient and their physician can do is attempt to control the disease. For millions of patients this means a daily regimen of pills, insulin injections or a combination of pills and injections.
As several respected scientist have pointed out there is no guarantee that a drug approved based on data from 24 or 36 month clinical trials won’t produce serious adverse events after being on the market for 5 or more years. This has lead some to call for the 7 year rule, which basically advises patients not to take any medication until it has been on the market for seven years. The problem with the seven year rule is that for patients with diabetes waiting seven years to use what appears to be an effective drug can have serious consequences. It’s a well known fact that the majority of patients with diabetes are not well controlled. Poorly controlled diabetes leads to several life threatening complications most notably cardiovascular problems.
At the end of this month the FDA will convene a panel meeting to examine Avandia and Actos and their possible link to cardiovascular issues. Diabetic Investor suspects this meeting won’t provide any clear answers as there are none. In this debate both sides will look at the same set of numbers and reach very different conclusions. As Fiorello La Guardia once said “Statistics are like alienists (i.e. psychiatrists) – they will testify for either side.”
With millions of patients and their physicians seeking clear guidance none will be forthcoming. In the meantime physicians are opting not to take any chances and are taking patients off Avandia. While it’s difficult to argue with this approach, it’s an open question whether or not this decision will benefit the patient in the long run. Diabetic Investor would have more confidence in this approach if patients were closely monitored and physicians were more aggressive when current treatment regimens do not produce solid control. Unfortunately this is not the case all too often physicians wait far too long before changing a patients treatment regimen. This treat to failure mentality increases the likelihood the patient will develop complications, it’s well documented that the more aggressively diabetes is treated the greater chance the patient has to avoid serious complications.
Compounding the problem is this new attitude that regular glucose monitoring is useless for non-insulin type 2 patients. Used properly regular glucose monitoring can detect signs of treatment failure. Yet there is a growing attitude that this sizable patient population shouldn’t even bother to check their glucose levels. In Diabetic Investor’s opinion this movement will only make a bad situation worse. Still the major blood glucose monitoring are sitting on the sidelines and letting this foolish school of thought gain traction. If things keep going in this direction they will only have themselves to blame when insurance companies decide to stop reimbursing non-insulin using patients for test strips.
When it’s all said and done the big losers will be the more than 12 million patients who do not use insulin. Instead of working to improve diabetes education for both patients and physicians, the diabetes powers that be are working on the stupidest concept of all – changing A1C from a simple and easy to understand number to a new number that no one but these people understand. Diabetes is growing at epidemic rates and shows no signs of weakening. Patients and their physicians are seeking, actually screaming for clear guidance. Study after study points to the benefits of education and regular glucose monitoring.
We are years, more likely decades away from a cure. Diabetes is not going away. Besides the human toll the economic consequences are equally severe. It would seem logical given this set of circumstances the ADA and the entire diabetes industry would stand united and demand that something be done. Nope. Instead they are wasting time and valuable resources on silly projects that if adopted will only make matters worse.
As Woodrow Wilson once said “In public affairs, stupidity is more dangerous than knavery.”